Clinical Trial of TQB3702 Tablets in Subjects With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT06859931
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-03-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TQB3702 Tablets
Administer orally on an empty stomach, once daily, for 24 consecutive weeks.
TQB3702 Tablets
TQB3702 is a selective kinase inhibitor.
TQB3702 Tablets+TQB3702 Placebo
Administer orally on an empty stomach, once daily, for 24 consecutive weeks. Placebo was administered orally once a day for 24 weeks.
TQB3702 Tablets+TQB3702 Placebo
TQB3702 is a selective kinase inhibitor； A placebo is a simulated drug whose physical properties, such as appearance, size, color, dosage form, weight, taste, and odor are substantially the same as the test drug, but cannot contain the active ingredients of the test drug.
TQB3702 Placebo
Placebo was administered orally once a day for 24 weeks.
TQB3702 Placebo
TQB3702 Placebo without drug substance.
Interventions
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TQB3702 Tablets
TQB3702 is a selective kinase inhibitor.
TQB3702 Tablets+TQB3702 Placebo
TQB3702 is a selective kinase inhibitor； A placebo is a simulated drug whose physical properties, such as appearance, size, color, dosage form, weight, taste, and odor are substantially the same as the test drug, but cannot contain the active ingredients of the test drug.
TQB3702 Placebo
TQB3702 Placebo without drug substance.
Eligibility Criteria
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Inclusion Criteria
* Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent);
* The diagnosis meets the classification criteria of SLE established by the International Clinical Collaboration on Lupus Research (SLICC) in 2012 and has been in place for at least 6 months (Appendix 16), excluding drug-related lupus;
* Meet the Systemic lupus erythematosus disease activity index-2K score requirements
* Positive for one or more of the following antibodies: positive for anti-nuclear antibodies (ANA titers greater than or equal to 1:80 by immunofluorescence) and/or positive for anti-DSDNA antibodies and/or positive for anti-Smith(anti-SM);
* Subjects were receiving standard treatment for SLE and had received treatment for at least 3 months prior to randomization. Standard therapeutic doses of SLE were stable for at least 30 days and glucocorticoids were stable for at least 2 weeks prior to initial administration. The standard treatment for SLE may be corticosteroids, and/or antimalarial drugs, and/or immunosuppressants
* At the time of screening, if the subject is taking an angiotensin-converting enzyme inhibitor or an angiotensin-II receptor blocker or a non-steroidal anti-inflammatory drug (NSAID) orally, it must be at least 2 weeks since the pre-screening dose stabilized;
* Subjects must stop all opioids at least 1 week before the first dose;
* Fertile subjects must consent to and commit to using a medically accepted form of contraception throughout the study period and for at least 6 months after the final trial drug administration.
Exclusion Criteria
* Severe lupus nephritis within 30 days prior to initial administration;
* Central nervous system diseases caused by SLE or not caused by SLE in the 12 months before the first dose;
* Current or past autoimmune diseases other than SLE
* There is an active and uncontrolled infection, or an infection that has recently required intravenous anti-infective therapy, or is currently being treated for any chronic infection
* Subjects whose chest radiology within 6 months prior to screening indicates active tuberculosis
* Have active hepatitis, or hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive + hepatitis B virus (HBV) DNA positive, or hepatitis C virus (HCV) RNA positive; Or a history of human immunodeficiency virus (HIV) infection, or a positive HIV serological result at screening; The specific antibody of Treponema pallidum was positive and the confirmatory test was positive. If HBV core antibody is positive but HBV-DNA is negative, HBV-DNA should be monitored once every 3 months.
* Herpes or shingles infection, or a history of disseminated/complicated shingles in the 12 weeks prior to screening;
* Cardiovascular and cerebrovascular abnormalities;
* Have a lung disease that the investigator determines is not suitable for participation in the study
* Subjects with a history or suspected demyelinating disease of the central nervous system;
* Subjects with a history of or suspected demyelinating disease of the central nervous system;
* Subjects with any type of active malignancy or with a history of malignancy;
* Have a history of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
* The subject has any medical condition that may affect the absorption of oral medications (e.g., bariatric/obesity surgery, or the subject is unable to take oral medications;
* Previous use of specific drugs;
* Patients who underwent plasma replacement within 12 weeks prior to initial administration or treated with human immunoglobulin 4 weeks prior to initial administration;
* Cyclophosphamide had been used within 3 months before the first dose;
* Rituximab or any other B-cell depletion therapy within 6 months prior to initial administration;
* Use Beliuzumab, Taitacept, tumor necrosis factor (TNF) antagonists, or other biologics before initial administration unless the elution time is met, as specified in Appendix 17;
* Participants who have suffered a major trauma, fracture, or surgical procedure in the 4 weeks prior to screening, or who are expected to require major surgical procedures during the study period;
* Participants who received live attenuated vaccine within 28 days before the start of study treatment, inactivated vaccine within 7 days, or planned vaccination during the study period.
18 Years
70 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affilliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The People's Hospital of Gansu Province
Lanzhou, Gansu, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Shenzhen second people's hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Hebei petro China central hospital
Langfang, Hebei, China
The second hospital of hebei medical university
Shijiazhuang, Heibei, China
Puyang Oilfield General Hospital
Puyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Shiyan People's Hospital
Shiyan, Hubei, China
Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Third Hospital of Central South University
Changsha, Hunan, China
Shaoyang Central Hospital
Shaoyang, Hunan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Meihekou Central Hospital
Meihekou, Jilin, China
Shenjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The First Hospital Affiliated to the Army Medical University
Xi'an, Shaanxi, China
Affiliated hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, China
Shanghai Jiao Tong University School of Medicine，Renji Hospital
Shanghai, Shanghai Municipality, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
First Hospital of Shangxi Medical University
Taiyuan, Shanxi, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
Mianyang central hispital
Mianyang, Sichuan, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Third People's Hospital of Yunnan Province
Kunming, Yunnan, China
Pu'er People's Hospital
Pu'er, Yunnan, China
Taizhou Central Hospital（Taizhou University Hospital）
Taizhou, Zhejiang, China
The 1th School of Medicine,School of Information and Engineering,The 1th Affiliated Hospital of WMU
Wenzhou, Zhejiang, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQB3702-II-01
Identifier Type: -
Identifier Source: org_study_id
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